Defibrotide for the Treatment of Severe COVID-19

Description

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

Conditions

Covid19

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Study Overview

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Study Details

Study overview

The goal of this study is to evaluate the safety and feasibility of defibrotide in COVID-19 pneumonia.

A Single-Arm Safety and Feasibility Study of Defibrotide for the Treatment of Severe COVID-19

Defibrotide for the Treatment of Severe COVID-19

Condition
Covid19
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 years.
  • 2. Active COVID-19 infection confirmed by positive SARS-CoV-2 PCR.
  • 3. Radiographic evidence of bilateral pulmonary infiltrates.
  • 4. A life expectancy of at least 24 hours.
  • 5. Score of 4-7 on the WHO ordinal scale.
  • 6. Prophylactic dose anticoagulation is allowed for enrollment into cohort 1. Therapeutic dose anticoagulation for active thrombosis, ECMO, and/or continuous renal replacement therapy (CRRT) is allowed for enrollment into cohort 2 if there is no evidence of bleeding after at least 24 hours of anticoagulation.
  • 7. Patient or surrogate able to provide informed consent
  • 1. Clinically significant acute bleeding.
  • 2. Concomitant use of thrombolytic therapy (e.g. t-PA).
  • 3. Hemodynamic instability, defined as a requirement for \>1 vasopressor agent for enrollment into cohort 1, and a requirement for \>2 vasopressor agents for enrollment into cohort 2
  • 4. Known allergy or hypersensitivity to DF.
  • 5. Pregnant or lactating.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Brigham and Women's Hospital,

Study Record Dates

2025-03-01